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Women's Healthy Eating and Living Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003787
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : June 10, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
John P. Pierce, University of California, San Diego

Tracking Information
First Submitted Date November 1, 1999
First Posted Date June 3, 2004
Last Update Posted Date June 10, 2019
Study Start Date March 1995
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2014)
Breast Cancer Recurrence [ Time Frame: Lifetime ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2014)
Mortality [ Time Frame: Lifetime ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women's Healthy Eating and Living Study
Official Title Dietary Intervention in Women Who Have Been Treated For Stage I, Stage II, or Stage III Breast Cancer: Women's Healthy Eating and Living (WHEL) Study
Brief Summary

RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence.

PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.

Detailed Description

OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat is associated with a longer breast cancer event-free interval in breast cancer survivors. II. Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary pattern that is rich in vegetables, fruit, and fiber and low in fat. III. Demonstrate that the intervention can produce significant changes in circulating carotenoid and estrogen biomarkers compared to a healthy control diet. IV. Test whether the probability of a secondary cancer event is associated with change in self-reported dietary intake, circulating carotenoid concentrations, and circulating estrogen concentrations.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary regimens: Arm I: Patients are taught to follow a dietary pattern that will produce significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are assigned to follow dietary guidelines established by the National Cancer Institute and the USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a randomly selected 50% sample participate in recall at 6 months. Patients are followed by telephone every 6 months for an average of 6 years.

PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, buffy coat, RBC, DNA at five time periods
Sampling Method Non-Probability Sample
Study Population Women who were diagnosed with early-stage breast cancer within the previous 4 years, and are between the ages of 18-74
Condition Breast Cancer
Intervention
  • Behavioral: educational/counseling intervention
  • Behavioral: therapeutic dietary intervention
Study Groups/Cohorts
  • Intervention
    high fiber, high vegetable, low-fat diet
    Interventions:
    • Behavioral: educational/counseling intervention
    • Behavioral: therapeutic dietary intervention
  • Control
    NCI-recommended diet
    Intervention: Behavioral: therapeutic dietary intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019)
3088
Original Enrollment Not Provided
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS: Primary operable stage I (tumors at least 1 cm), stage II, and stage IIIA invasive breast carcinoma Treatment within the past 4 years by total mastectomy and axillary dissection, or breast sparing surgical removal of cancer with clear macroscopic margins and axillary dissection followed by adjuvant breast radiation No evidence of recurrent disease or new breast cancer since completion of initial local treatment confirmed within the past 6 months by physician evaluation, except stage I mastectomy, for which physician evaluation can be within 1 year prior to randomization Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 70 at time of diagnosis Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (excluding breast cancer) Hematopoietic: Not specified Hepatic: No cirrhosis Renal: Not specified Other: Not pregnant Accessible geographically and by telephone Able to communicate dietary data via 24-hour food recall Able to commit to the intervention schedule No comorbidity requiring a specific diet or taking a medication which contraindicates consuming a high fiber diet (e.g., systemic scleroderma, other digestive malabsorption syndromes, and insulin dependent diabetes) No other primary or recurrent invasive cancer within the past 10 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent estrogen replacement therapy, including vaginal estrogen creams Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent enrollment in another clinical trial that has dietary restrictions or endpoints similar to this study

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00003787
Other Study ID Numbers UCSD-980919
CDR0000066920 ( Registry Identifier: PDQ (Physician Data Query) )
UCSD-WHEL
NCI-G99-1508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party John P. Pierce, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators
  • National Cancer Institute (NCI)
  • Susan G. Komen Breast Cancer Foundation
Investigators
Study Chair: John P. Pierce, PhD University of California, San Diego
PRS Account University of California, San Diego
Verification Date June 2019